NCT03653260已完成3 期
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety in Chinese Children
Lee's Pharmaceutical Limited1 个研究点 分布在 1 个国家目标入组 288 人开始时间: 2018年8月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Wong-Baker FACES Pain Rating Scale After Venipuncture or Peripheral Cannulation
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of Zingo in treating pain associated with venipunture and peripheral venous cannulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female aged 3-12
- •About to undergo venipuncture or peripheral venous cannulation at the back of the hand or antecubital fossa
- •Have sufficient cognitive skills to identify faces depicting extremes of pain on the Wong-Baker FACES scale (age 3-12) and the extremes of pain on a 100 mm visual analog scale (VAS) (ages 8-12)
- •Signed informed consent, cooperative and agree to attend follow-up visits
排除标准
- •Any medical condition, non-compliance or instability (including but not limited to exceptionally upset, crying, anxiety) that in the judgement of the investigator might adversely affect the conduct of the study
- •Used any (including external or inhaled) sedatives, analgesics, anaesthetics or other agents/device that may affect the efficacy assessment
- •Subjects with tattoos, surgical scars, ports, implantable devices or a skin condition (e.g. excessive body hair) that may have interfered with the placement of Zingo or skin site assessments
- •Active local infection or other skin pathology at the site of venipuncture or peripheral venous cannulation.
- •Venipuncture of peripheral venous cannulation at the proposed site within the prior two weeks (longer if the wound is apparent)
- •Previous history of allergic reactions to any local anaesthetic or tape/adhesive dressing.
- •Participated in a clinical trial within three months prior to administration of study drug, or have already enrolled in a Zingo clinical trial before
- •At the discretion of the investigator, any subjects that may have to be withdrawn from the study
研究组 & 干预措施
Lidocaine (Zingo)
Experimental
0.5mg lidocaine at 20 bar pressure
干预措施: Lidocaine (Zingo) (Drug)
Placebo
Placebo Comparator
no emitted particle at 20 bar pressure, identical in external appearance to Zingo
干预措施: Placebo (Drug)
结局指标
主要结局
Wong-Baker FACES Pain Rating Scale After Venipuncture or Peripheral Cannulation
时间窗: immediate after venipunture
Child's assessment of pain on venipuncture or peripheral venous cannulation (all ages) performed one to three minutes after Zingo/Placebo administration, measured using the Wong-Baker FACES pain rating scale. The scale includes pictures of facial expressions with correlating numerical scale of 0-10, 0 being no hurt and 10 being the worst hurt.
次要结局
- 100-mm Visual Analogue Scale (VAS)(immediate after venipunture)
- Response Rate(immediate after venipunture)
- Compliance Score(immediate after venipunture)
研究者
研究点 (1)
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